| Title | What’s Next for MDMA | |
| Date | Saturday June 08, @05:08PM | |
| Author | janrinok | |
| Topic | ||
| from the party-time dept. | ||
MDMA, sometimes called Molly or ecstasy, has been banned in the United States for more than three decades. Now this potent mind-altering drug is poised to become a badly needed therapy for PTSD.
On June 4, the Food and Drug Administration's advisory committee will meet to discuss the risks and benefits of MDMA therapy. If the committee votes in favor of the drug, it could be approved to treat PTSD this summer. The approval would represent a momentous achievement for proponents of mind-altering drugs, who have been working toward this goal for decades. And it could help pave the way for FDA approval of other illicit drugs like psilocybin. But the details surrounding how these compounds will make the transition from illicit substances to legitimate therapies are still foggy.
[...] However, for drugs that carry a risk of serious side effects, the FDA can add a risk evaluation and mitigation strategy to its approval. For MDMA that might include mandating that the health-care professionals who administer the medication have certain certifications or specialized training, or requiring that the drug be dispensed only in licensed facilities.
For example, Spravato, a nasal spray approved in 2019 for depression that works much like ketamine, is available only at a limited number of health-care facilities and must be taken under the observation of a health-care provider. Having safeguards in place for MDMA makes sense, at least at the outset, says Matt Lamkin, an associate professor at the University of Tulsa College of Law who has been following the field closely.: "Given the history, I think it would only take a couple of high-profile bad incidents to potentially set things back."
What mind-altering drug is next in line for FDA approval?
Psilocybin, a.k.a. the active ingredient in magic mushrooms. This summer Compass Pathways will release the first results from one of its phase 3 trials of psilocybin to treat depression. Results from the other trial will come in the middle of 2025, which—if all goes well—puts the company on track to file for approval in the fall or winter of next year. With the FDA review and the DEA rescheduling, "it's still kind of two to three years out," Nath says.
Some states are moving ahead without formal approval. Oregon voters made psilocybin legal in 2020, and the drug is now accessible there at about 20 licensed centers for supervised use. "It's an adult use program that has a therapeutic element," says Ismail Ali, director of policy and advocacy at the Multidisciplinary Association for Psychedelic Studies (MAPS).
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printed from SoylentNews, What’s Next for MDMA on 2024-07-27 04:25:00